Multifrax激光系统
K号: K213332 · 2022-06-03
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决定日期2022-06-03
产品代码ONG
咨询委员会SU
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决定实质等同
器械摘要
Multifrax Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Medical Corporation. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K213332. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Multifrax Laser System?
Multifrax Laser System is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Paradigm Medical Corporation. The 510(k) number is K213332.
When did Multifrax Laser System receive FDA 510(k) clearance?
Multifrax Laser System received FDA 510(k) clearance on 2022-06-03, under 510(k) number K213332.
Who is the listed applicant for Multifrax Laser System?
The FDA 510(k) record lists Paradigm Medical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Multifrax Laser System?
The FDA product code for Multifrax Laser System is ONG.
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相关器械（代码：ONG）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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